High-protein plUs reSistance Training in gLucagon-like pEptide 1 Receptor Agonist Users (HUSTLE) (NCT07700030)
🩺 Plain-English Summary (8th-Grade Level)
The primary objective of this study is to examine the effects of a high-protein diet (HP) paired with resistance training (RT) compared with a HP diet alone, on skeletal muscle mass (SMM) volume of the (a) quadriceps and (b) rhomboids, and upper and lower body muscle strength in adults recently prescribed tirzepatide. The secondary objectives of this study are to compare changes in resting energy expenditure (REE), adaptive thermogenesis (AT), and body adiposity (SFV, VAT, and intramuscular FF) in the quadriceps and rhomboid muscles) between the high-protein diet with RT and the high-protein diet arms at 6 months.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (13 items) and avoid the listed exclusions (30 items).
Location: NYU Langone Health — New York, New York
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Patients currently prescribed oral or injectable incretin mimetics containing GLP-1RAs, including Exenatide, Liraglutide, Lixisenatide, Dulaglutide, Semaglutide. Participants who are currently prescribed tirzepatide and have been using for \>4 weeks will also be excluded.
- Prior use of incretin mimetics containing GLP-1RAs with \>3% weight loss in a 4-week period
- Lost \>5% body weight in the past 6 months
- Has consistently resistance trained (\>10 sessions) in the last year
- Currently taking medication or supplements that have been shown to impact muscle function and muscle mass in the last 6 months
- Participants who live outside of the tri-state area and/or are not willing to come to New York City for in-person visits outlined
- Plans to be out of town more than 2 consecutive weeks or \>6 weeks total over the next 6 months
- Type 1 or 2 diabetes; uncontrolled diabetes (e.g., HbA1c \> 6.4% if specified); recurrent severe hypoglycemia or hypoglycemia unawareness.
- Moderate-to-severe chronic kidney disease (e.g., eGFR \< 45-60 mL/min/1.73 m2 final cutoff per protocol) or other renal disease
- Decompensated cirrhosis, severe chronic liver disease, or active liver disease
- Unstable cardiovascular disease (e.g., myocardial infarction (MI), stroke, coronary revascularization, or hospitalization for unstable angina or decompensated heart failure (HF) within \<6 months)
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- NYU Langone Health — New York, New York
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.